Oncoinvent AS, a clinical stage radiopharmaceutical company, announced that its therapy Radspherin® has received Fast Track designation from the FDA for treating peritoneal metastases from ovarian cancer. This designation marks a significant milestone as Oncoinvent prepares to initiate a Phase 2b trial evaluating Radspherin®'s efficacy and safety. The Fast Track status highlights the critical need for effective treatments for peritoneal metastases, which severely impact life expectancy.
The upcoming Phase 2b trial will be a randomized, controlled study assessing Radspherin® in patients with peritoneal metastases from ovarian cancer. It aims to compare progression-free survival (PFS) between patients receiving Radspherin® after complete surgical resection and pre-operative chemotherapy versus those undergoing only chemotherapy and surgery. Previous Phase 1/2a trials showed that Radspherin® was well tolerated with no dose-limiting toxicity at the recommended dose of 7MBq.
Fast Track designation is designed to facilitate the development and expedite the review of therapies addressing serious conditions with unmet medical needs. This designation allows for more frequent interactions with the FDA and can lead to accelerated approval and priority review if criteria are met, potentially bringing important new medicines to patients earlier.
Oncoinvent's mission involves developing innovative radiopharmaceutical technologies that use alpha-emitting particles to target solid cancers. Their lead candidate, Radspherin®, aims to treat metastatic cancers in body cavities and is currently undergoing clinical trials for peritoneal carcinomatosis from both ovarian and colorectal cancers. The company's internal manufacturing and supply chain capabilities support the clinical supply of these novel therapies, advancing the potential of alpha particle radiation to eliminate cancer cells effectively.
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